11272VUE 11272VUEK Flexible Video Cysto-Urethroscope recall
11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope…
Why was 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope recalled?
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021) UDI Code: 4048551431382; 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021) UDI Code: 4048551444351; All Serial Numbers manufactured/distributed since January 2018.
- Product
- 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethroscope…
- Recalling firm
- Karl Storz Endoscopy
- Quantity
- All Serial Numbers manufactured/distributed since January 2018.
- Distribution
- U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA,WI, WV, and WY. O.U.S.: Mexico, Lebanon, and South Korea
- Recall date
- May 18, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)